Placebo controlled study on effects of vitamin D supplementation in type 1 diabetic subjects on immunological, endocrine and metabolic parameters: Step 2 of the Austrian Diabetes Prevention Programme (ADPP-002)
- Conditions
- To evaluate whether vitamin D supplementation in type 1 diabetic subjects significantly alters the proportion of regulatory T-cells of all circulating CD4 positive T-cells.
- Registration Number
- EUCTR2010-018901-12-AT
- Lead Sponsor
- Medical University Graz, Department of Internal Medicine, Div. Endocrinology and Metabolism
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Informed consent
Healthy volunteers with type 1 diabetic
Age of at least 6 years
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Hypercalcemia (>2,65mmol/L)
Pregnancy
Nursing women
Any disease that requires continuous treatment with medications
Intake of medication as part of another clinical trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate whether vitamin D supplementation in type 1 diabetic subjects significantly alters the proportion of circulating CD4 positive T-cells. in type 1 diabetic subjects ;Secondary Objective: To evaluate whether vitamin D supplementation significantly alters the insulin secretin (assessed by mixed<br>meal tolerance test), renin, aldosterone, osteoprotegerin, and asymmetric<br>dimethylarginine (ADMA) concentrations and the effect on different cytokine levels (IL1-beta, IL2, IL4, IL6,<br>IL10, MCP1, TNF-alpha, TGF-beta).;Primary end point(s): Changes in the proportion of regulartory T-cells of all circulating CD4 positive T-cells in type 1 diabetics
- Secondary Outcome Measures
Name Time Method